Identity
- Trade Name
- ihcDirect® Chromogranin A Ab Conjugate 5mL FDA UDI
- Generic Name
- Chromogranin A IVD, antibody FDA UDI
- Device Name
- Clone R1004 FDA UDI
- Model / Reference
- H32035-R005 FDA UDI
- Description
- Clone R1004 FDA UDI
Identifiers
- Catalog Number
- K32035-005 FDA UDI
- Primary DI / UDI-DI
- 00850030934550 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Chromogranin A IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Chromogranin A IVD, antibody
ihcDirect® Chromogranin A Ab Conjugate 5mL by Novodiax, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Chromogranin A IVD, antibody.
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- Chromogranin A (LK2H10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human Chromogranin A Antibody, EP38 — EPITOMICS, INC. · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Novodiax, Inc.
Sources (1)
- FDA UDI 96a9866b-efd4-49d9-a432-a14b7cee07d0 37 fields · synced May 30, 2026